Your Simvastatin Side Effect submission can play a very important role. Reporting your experience could help identify an unknown risk and inform other patients and health care professionals.
How Can Simvastatin Affect You?
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View Simvastatin Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)
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Did You Have a Simvastatin Side Effect?
How Effective is Simvastatin for You?
Alternative SIMVASTATIN Names:SIMVASTAT
Active Ingredient: SIMVASTAT
Side Effects reported to FDA: 6536. View Simvastatin Adverse Reports
Reported deaths: 418
Reported hospitalizations: 2451
Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations
Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor
[UPDATED 12/15/2011] FDA notified the public that it has revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction.
AUDIENCE: Family Practice, Cardiology, Pharmacy
ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.
BACKGROUND: The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).
RECOMMENDATION: Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.
Previous MedWatch Alert
Have Your experienced Simvastatin Side Effects? You are not alone. Many patients report unusual symptoms after using Simvastatin. PatientsVille.com raises awareness about Drug Side Effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.